Multi-purpose catheter apparatus and method of use

• US 20050010095A1
• Filed: 05/03/2004
• Published: 01/13/2005
• Est. Priority Date: 04/05/1999
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sandstrom, Jeffrey D., Stewart, Mark T., Fiedler, Gary R.
• Application Number:
  US10/837,947
• Publication Number:
  US 20050010095A1
• Time in Patent Office: Days
• US Class Current: 600/374
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00898 Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2218/002 Irrigation

Abstract

According to the present invention, a catheter having at least one multi-purpose lumen formed through the catheter terminates proximal a relatively complex-shaped distal portion thereof. In one form of this embodiment, the relatively complex-shaped distal portion comprises a looped portion having diagnostic- and/or ablation-type electrodes coupled thereto and an elongated diameter-adjusting member coupled proximal the distal end of the looped portion. The multi-purpose lumen may be used to alternately accommodate a variety of dedicated materials; such as, (i) a guide wire for initial deployment or later repositioning of the catheter, (ii) a volume or flow of a contrast media and the like, (iii) a deployable hollow needle or tube and the like used to biopsy adjacent tissue or dispense a therapeutic agent into a volume of tissue, and (iv) a cooling fluid, such as saline solution and the like dispensed at least during therapeutic tissue ablation procedures.

Claims

1. An elongated catheter assembly having at least one adjustable-diameter loop, comprising:

a distal portion, said distal portion further comprising at least one loop;

means for adjusting a diameter dimension of the at least one loop; and

an electrode section disposed about the at least one loop, said electrode section further comprising a plurality of individually addressable discrete electrically conducting electrode members coupled to at least one elongated electrical conductor adapted for electrical communication with remote circuitry.

2. An elongated catheter assembly according to claim 1, wherein said means for adjusting comprises a one of:

a resilient unitary wire, a braided wire cable, a coiled wire cable, and wherein said means for adjusting is slideably disposed within said distal portion.

3. An elongated catheter assembly according to claim 2, further comprising a sheath slideably coupled around said means for adjusting.

4. An elongated catheter assembly according to claim 1, further comprising at least one lumen formed through at least the distal portion.

5. An elongated catheter assembly according to claim 4, further comprising a fluid reservoir removeably coupled to a proximal end portion of the irrigation/guide-wire lumen.

6. An elongated catheter assembly according to claim 4, further comprising a contrast media lumen.

7. An elongated catheter assembly according to claim 4, further comprising a fluid reservoir removeably coupled to the at least one lumen.

8. An elongated catheter assembly according to claim 2, wherein said means for adjusting is slideably coupled within an inner circumference of an interior wall of the second conduit.

9. An elongated catheter assembly according to claim 1, further comprising a tip portion extending distally from the at least one loop.

10. An elongated catheter assembly according to claim 1, further comprising a remote electronic signal processing unit adapted to be electrically coupled to the plurality of individually addressable discrete electrically conducting electrode members.

11. An elongated catheter assembly according to claim 10, wherein:

upon activation of a tissue mapping circuit the remote electronic signal processing unit measures electrical signals from the electrode members; and

upon activation of a tissue ablation circuit the remote electronic signal processing unit provides a predetermined amount of ablation energy to form a tissue lesion region proximate one or more of the electrode members.

12. An elongated catheter assembly according to claim 1, wherein said at least one loop comprises a helical loop member and wherein each successive one of the series of helical loop members has a smaller diameter dimension than a prior helical loop member.

26. An elongated catheter assembly according to claim 1, wherein at least a segment of the distal portion comprises a distally decreasing radius helix.

13. An elongated catheter apparatus, comprising:

an elongated catheter body;

a helical distal portion coupled to the elongated catheter body;

an elongated diameter-adjusting member disposed within the elongated catheter body and the helical distal portion and having a distal end mechanically coupled proximal to a distal end portion of the helical distal portion so that a diameter dimension of the helical distal portion decreases when tension is applied to the elongated diameter-adjusting member;

at least one electrode mechanically coupled to a portion of the helical distal portion; and

a multi-purpose lumen disposed within said catheter body from a proximal end to a location just proximal the helical distal portion and wherein a longitudinal axis of said lumen is disposed substantially orthogonal to the plane defined by the helical distal portion.

14. An elongated catheter apparatus according to claim 13, further comprising a shaping wire mechanically coupled to at least the helical distal portion.

15. An elongated catheter apparatus according to claim 14, wherein said shaping wire comprises a superelastic material.

16. An elongated catheter apparatus according to claim 14, wherein said shape memory material comprises a nitinol material.

17. An elongated catheter apparatus according to claim 14, wherein said shaping wire is mechanically anchored to a distal tip of the elongated catheter apparatus.

18. An elongated catheter apparatus according to claim 17, wherein said shaping wire slideably couples to an inner circumference of the helical distal portion.

19. An elongated catheter apparatus according to claim 13, wherein said helical distal portion comprises a successively increasing diameter helix.

21. An elongated catheter apparatus according to claim 13, further comprising a plurality of electrodes mechanically coupled to the helical distal portion and electrically coupled to the at least one conductor.

22. An elongated catheter apparatus according to claim 13, further comprising at least a one of:

a contrast media fluid source fluidly coupled to said multi-purpose lumen;

a manually deployable biopsy instrument disposed in said multi-purpose lumen; and

a manually deployable fluid injecting instrument disposed in said multi-purpose lumen.

23. An elongated catheter apparatus according to claim 13, further comprising an irrigation fluid conduit formed through at least the elongated catheter body.

24. An elongated catheter apparatus according to claim 23, further comprising a fluid reservoir removeably coupled to a proximal end of either the multi-purpose lumen or the irrigation fluid conduit.

25. An elongated catheter apparatus according to claim 24, further comprising a diagnostic electrical signal processor or an ablation signal generator coupled to the second end of the at least one conductor.

27. An elongated catheter apparatus according to claim 23, wherein a distal end portion of the irrigation lumen terminates distal the at least two electrodes and wherein at least a portion of the distal end portion of the irrigation lumen is formed of a microporous polymer material.

28. A catheter assembly of claim 27, wherein the microporous polymer material comprises a high-density, expanded PTFE material.

29. A catheter assembly of claim 13, wherein the at least two electrodes comprise a coil electrode.

20. An elongated catheter apparatus 13, further comprising a pull wire coupled to a location proximal the helical distal portion so that when tension is applied to said pull wire the helical distal portion deflects from a longitudinal axis of said intermediate portion.

30. A method of reaching a desired target through a confined vessel with a deployable electrical catheter having electrodes disposed on an adjustable-diameter loop portion and remotely adjusting the diameter of said loop portion, comprising:

advancing a delivery catheter containing a deployable electrical catheter assembly through a confined vessel to a location adjacent a desired target, said deployable electrical catheter assembly including a proximal portion, an intermediate portion, and a temporarily collapsed, expandable distal portion;

withdrawing the delivery catheter until at least the temporarily collapsed, expandable distal portion extends from the distal end of said delivery catheter, said temporarily collapsed, expandable distal portion further comprising;

an adjustable-diameter loop portion that in an expanded state is oriented substantially transverse to the longitudinal axis of the intermediate portion;

means for expanding the adjustable-diameter loop portion from a compact collapsed state to the expanded state;

a loop diameter-adjustment assembly slideably coupled to the proximal portion, the intermediate portion and the distal portion, and wherein a first end of the loop diameter-adjustment assembly connects to a distal part of the adjustable-diameter loop portion and a manually accessible second end; and

at least one electrode coupled to the adjustable-diameter loop portion;

expanding the loop portion to a predetermined curvilinear shape by operation of the means for expanding;

manipulating the loop diameter-adjustment assembly to adjust a diameter dimension of the loop portion to a desired dimension;

advancing the loop portion such that at least a portion of the adjustable-diameter loop portion contacts the desired target; and

activating a remote signal processor or signal generator to respectively diagnose an electrical condition of, or ablate a lesion pattern on, the desired target.

31. A method according to claim 30, wherein the means for expanding the adjustable-diameter loop portion from a compact collapsed state to the expanded state comprises at least a one of:

an elongated shape memory material disposed within at least the adjustable-diameter loop portion,

a wire connected to the distal part of the adjustable-diameter loop portion,

a resilient elongated member connected to the distal part of the adjustable-diameter loop portion.

32. A method according to claim 30, wherein the loop diameter-adjustment assembly further comprises a one of:

a resilient unitary wire,

a braided wire cable,

a coiled wire cable, and

wherein said loop diameter-adjustment assembly slideably couples to the proximal portion, the intermediate portion and the distal portion.

33. An adjustable-diameter catheter assembly, comprising:

a distal portion having at least one longitudinal conduit and at least one arcuate portion, said arcuate portion including a first relative diameter;

a multi-purpose lumen disposed from a proximal portion to a location proximal said distal portion; and

an elongated diameter-adjusting member disposed in the at least one longitudinal conduit and mechanically coupled to said distal portion proximal an end portion of the arcuate portion,

wherein tension applied to the elongated diameter-adjusting member causes a decrease in the first relative diameter of the arcuate portion.

34. A multi-purpose catheter, comprising:

a catheter body;

a multi-purpose lumen disposed in said catheter body through an intermediate portion thereof;

a port fluidly coupling the multi-purpose lumen disposed at the terminus of the intermediate portion;

a distal portion coupled to the end of the intermediate portion;

wherein said distal portion further comprises;

at least one loop portion; and

at least two electrodes are coupled to said at least one loop portion.

35. A multi-purpose catheter according to claim 34, wherein said multi-purpose lumen is adapted to at least temporarily receive each of the following:

an elongated guide-wire;

an elongated tissue collection instrument;

an elongated tissue-piercing, fluid dispensing instrument;

a volume of contrast media;

a volume of a fluid material.

36. A multi-purpose catheter according to claim 34, wherein said port further comprises a valve member disposed over all or substantially the entire open surface area of said port.

37. A multi-purpose catheter according to claim 36, wherein said valve member comprises at least two substantially opposing flaps.

38. A multi-purpose catheter according to claim 34, wherein the distal portion of the catheter has a reduced diameter relative to an intermediate or proximal portion of the catheter.

39. A multi-purpose catheter according to claim 34, wherein said catheter is sized for access of a vessel of a body to ablate tissue either adjacent at least one stent previously deployed in said vessel or at a location wherein a stent is scheduled to be deployed.

40. A multi-purpose catheter according to claim 35, wherein said catheter is disposed adjacent a myocardiac infarction and either the elongated biopsy collection instrument is deployable therefrom or the elongated tissue-piercing, fluid dispensing instrument is deployable therefrom.